DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 19 and 21-22 are cancelled.
Claims 1-18, 20, and 23-24 are included in the prosecution.
Claim Interpretation
Examiner acknowledges the synonyms of Methisoprinol as defined in the specification, “Methisoprinol, also known as Inosine pranobex, isoprinosine or inosine dimepranolacedoben”, and applies the broadest reasonable interpretation by also using these synonyms in the search and examination of the claims.
Allowable Subject Matter
Claim 14 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 15 and 20 are free of the art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 4, 7, 8, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 3, the phrase "such as" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claims 4, 7, and 8, the phrase "preferably " renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim 20 is indefinite for reciting the acronym “SS” without defining what “SS” represents. The instant claim and the instant specification do not define this acronym. Examiner requests the acronym be spelled out.
Appropriate correction is required.
Claim Rejections – 35 U.S.C. 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-13, 16-18, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Wahl et al. (US 20200138709 A1) hereinafter Wahl.
Regarding claims 1-13, 16-18, and 23-24, Wahl is drawn to a pharmaceutical composition in the form of an aqueous solution, containing inosine pranobex, characterised in that it contains a solubilizer from the group of hydroxy alcohols or mixtures thereof, preferably propylene glycol, glycerol, preservatives selected from the group of parahydroxybenzoic acid esters and mixtures thereof, preferably methyl parahydroxybenzoate, propyl parahydroxybenzoate, and pH regulators in the range from 5.7 to 12.0, and a method of preparation thereof (abstract and claims 1-6).
Wahl discloses a pharmaceutical composition in the form of an aqueous solution, containing inosine pranobex, characterised in that it contains a solubilizer from the group of hydroxy alcohols or mixtures thereof, preferably propylene glycol, glycerol, preservatives selected from the group of parahydroxybenzoic acid esters and mixtures thereof, preferably methyl parahydroxybenzoate, propyl parahydroxybenzoate, and pH regulators in the range from 5.7 to 12.0. It is also preferred for the composition contains from 0.05% to 13% inosine pranobex (overlaps with 2.5% to 15% which is 25 mg/ml to 150 mg/ml) [0003].
Wahl discloses a method of preparation of the composition in that it comprises:
a) dissolving the sweetener in water; b) cooling the solution from step a); c) adding to the solution from step b) a solubilizer from the group of hydroxy alcohols or mixtures thereof; d) adding to the solution of step c) preservatives selected from the group of parahydroxybenzoic acid esters and mixtures thereof until dissolution; e) cooling the solution from step d); f) adding the sweetener to the solution of step e); g) adding pH regulators; h) sequentially adding, until dissolution, inosine pranobex and then zinc gluconate, followed by cooling, and preferably adding the aroma [0004].
Wahl discloses it is possible to obtain a liquid form of the drug, which is characterised by stability despite the use of two active ingredients, and a better taste than medicinal products containing only inosine pranobex [0005].
Wahl does not explicitly disclose each of the components of the composition in a single embodiment.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wahl, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Wahl discloses all the required components and Wahl discloses it is possible to obtain a liquid form of the drug, which is characterised by stability despite the use of two active ingredients, and a better taste than medicinal products containing only inosine pranobex [0005]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
Claim 15 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615